Efficacy and Safety Study of Ultrasound Bone Strength Device to Measure Calcaneal Bone Strength Index of Human Subjects

Nanjing Medical University

Status: Completed

Conditions: Clinical Trial; Equipment Safety; Comparative Effectiveness Research

Treatments: Device: SONOST3000; Device: Oste-scan 500A

Study type: Interventional

Funder types: Other

Identifiers

NCT02971527

HJHC-YLQX2016001

Details and patient eligibility

About

The purpose of this study is to examine whether ultrasound bone strength device (Model Number: Oste-scan 500A) is effective and safe in measuring calcaneal bone strength index of human subjects, compared with a listed, similar device (Model Number: SONOST3000).

Full description

This study adopt a method of multicenter, open-labeled, self-paired design. Each subject will be randomly assigned to two different detective sequence groups. In one group, the investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device firstly and then by control device. In another group, the investigators will detect the same calcaneus of each subject by control ultrasound bone strength device firstly and then by experimental device. Experimental ultrasound bone strength device is developed by Wuxi Huajian Hengchuang Medical Equipment Science and Technology Co., Ltd.. This device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G). Control ultrasound bone strength device which has same clinical indications and action mechanism with the experimental one, is manufactured by Osteosys Co., Ltd.. This device's model number is SONOST3000.

Enrollment: 150 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject who need to measure calcaneal bone strength index.
• Subject is a male or female subject 20-80 years of age.
• Subject is willing and able to provide signed and dated written informed consent form.
• Subject whose compliance is good and can cooperate to complete the clinical trial.

Exclusion criteria

• Subject whose heel skin fester or defect.
• Subject has a history of allergic reactions to ultrasonic coupling agent.
• Subject who is not cooperative obviously or nervous extremely.
• Pregnant or lactating females.
• Subject has a mental disease, without self-control.
• Subject has participated in other clinical trial within a month.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Oste-scan 500A-SONOST3000

Experimental group

Description:

In this group, the investigators will measure calcaneal bone strength index of each subject by experimental device firstly and then by control device.

Treatment:

Device: Oste-scan 500A

Device: SONOST3000

SONOST3000-Oste-scan 500A

Experimental group

Description:

In this group, the investigators will measure calcaneal bone strength index of each subject by control device firstly and then by experimental device.

Treatment:

Device: Oste-scan 500A

Device: SONOST3000